Administrative Order No. 2020-010 || Regulations on the Conduct of Clinical Trials for Investigational Products

This Administrative Order aims to achieve the following:

  1. Ensure the full protection of the rights and safety of human subjects and the integrity of clinical trial data through the adoption and implementation of International Council of Harmonization-Good Clinical Practice (ICH GCP) standards;
  2. Ensure efficient and effective process for the approval of clinical trials;
  3. Provide standards and requirements for the regulation and importation of Investigational Products; and
  4. Strengthen the monitoring of compliance of all organizations, institutions and entities to GCP and other related FDA regulations through regulatory inspections.

Read more:->Administrative Order No.2020-010

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